pepcid complete

Generic: famotidine, calcium carbonate, and magnesium hydroxide

Labeler: morning star otc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pepcid complete
Generic Name famotidine, calcium carbonate, and magnesium hydroxide
Labeler morning star otc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

calcium carbonate 800 mg/1, famotidine 10 mg/1, magnesium hydroxide 165 mg/1

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-4001
Product ID 53209-4001_37e8dec7-0fdb-a2b0-e063-6394a90abfc8
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020958
Listing Expiration 2026-12-31
Marketing Start 2025-06-19

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 532094001
Hyphenated Format 53209-4001

Supplemental Identifiers

RxCUI
283641 688892
UNII
H0G9379FGK 5QZO15J2Z8 NBZ3QY004S
NUI
N0000000151 N0000175784

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pepcid complete (source: ndc)
Generic Name famotidine, calcium carbonate, and magnesium hydroxide (source: ndc)
Application Number NDA020958 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
  • 10 mg/1
  • 165 mg/1
source: ndc
Packaging
  • 25 BLISTER PACK in 1 PACKET (53209-4001-2) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1)
source: ndc

Packages (1)

53209-4001-2 25 BLISTER PACK in 1 PACKET (53209-4001-2) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1)

Ingredients (3)

calcium carbonate (800 mg/1) famotidine (10 mg/1) magnesium hydroxide (165 mg/1)

Linked Drug Pages (1)

Pepcid Complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37e8dec7-0fdb-a2b0-e063-6394a90abfc8", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["H0G9379FGK", "5QZO15J2Z8", "NBZ3QY004S"], "rxcui": ["283641", "688892"], "spl_set_id": ["be7f97d5-d2f2-45a8-96b4-fed1549ae2a3"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "25 BLISTER PACK in 1 PACKET (53209-4001-2)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1)", "package_ndc": "53209-4001-2", "marketing_start_date": "20250619"}], "brand_name": "Pepcid Complete", "product_id": "53209-4001_37e8dec7-0fdb-a2b0-e063-6394a90abfc8", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "53209-4001", "generic_name": "Famotidine, Calcium carbonate, and Magnesium hydroxide", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepcid Complete", "active_ingredients": [{"name": "CALCIUM CARBONATE", "strength": "800 mg/1"}, {"name": "FAMOTIDINE", "strength": "10 mg/1"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "165 mg/1"}], "application_number": "NDA020958", "marketing_category": "NDA", "marketing_start_date": "20250619", "listing_expiration_date": "20261231"}